The European Commission has published the latest PMSV (Post-Market Surveillance and Vigilance) reporting forms, which apply to manufacturers of medical devices and in vitro diagnostic medical devices under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
These forms are intended to:
- Improve consistency in incident and field safety reporting across Member States
- Support effective communication between manufacturers and competent authorities
- Strengthen the overall safety monitoring framework in the EU market
There is a six 6 month transition period, as the new MIR Form 7.3.1 becomes mandatory as from November 2025. This gives the economic operators the necessary time to accommodate this change in their internal management systems and adapt, as appropriate, their associated procedures and documentation.
📎 Access the new forms and guidance, here.
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